The FDA granted accelerated approval on October 19, 2026, for rectal cancer immunotherapy that may help certain adults avoid chemotherapy, radiation and surgery. The new use of Jemperli (dostarlimab-gxly) applies only to previously untreated stage II or stage III locally advanced rectal cancer with specific tumor characteristics. For related background, see Jessie J Undergoes Surgery for Breast Cancer.
The FDA announcement describes encouraging trial results, but the approval does not mean every eligible patient can avoid other treatment. Longer follow-up is needed to establish how long responses last and how often cancer returns.
Who qualifies for rectal cancer immunotherapy?
The approval covers Jemperli used alone in adults whose cancer is stage II or III and has not previously been treated. At these stages, the cancer has grown into nearby tissue or reached nearby lymph nodes, but has not spread to distant organs.
Eligibility also requires a tumor that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), as determined by an FDA-authorized test. According to published estimates cited by the FDA, approximately 3% of locally advanced rectal cancers have these characteristics.
Both terms describe problems with the system that repairs errors when cells copy their DNA. When that system fails, errors accumulate and produce proteins the immune system can recognize. This makes these tumors particularly vulnerable to immunotherapy.
How Jemperli works—and why avoiding other treatments matters
Jemperli targets PD-1, a protein on immune cells. By blocking a signal cancer cells use to shield themselves from the immune system, the medicine helps the immune system act against the cancer.
Patients with locally advanced rectal cancer often receive chemotherapy and radiation before surgery. The FDA notes that these treatments can affect bowel, urinary and sexual function, as well as fertility. Surgery carries additional risks, including poor healing, leaks where the bowel is reconnected and, for some patients, a permanent colostomy. For related background, see Pancreatic Cancer: Symptoms, Treatment, and Chemotherapy.
The potential benefit is therefore not only treating the cancer, but allowing some patients to avoid treatments with lasting effects on daily life. Readers exploring this broader treatment category can also find related coverage of immunotherapy for lung cancer; the eligibility and findings described here apply specifically to this rectal cancer approval.
What the clinical studies found
The FDA based its decision on interim results from AZUR-1, a phase 2 study involving 154 patients with previously untreated dMMR or MSI-H locally advanced rectal cancer. After a median follow-up of more than two years, almost three-fourths had not needed surgery, radiation or chemotherapy. Median follow-up means at least half had been monitored for that long.
An earlier Memorial Sloan Kettering Cancer Center study evaluated Jemperli alone in 50 patients with the same disease characteristics. None had detectable signs of cancer after treatment, and 93% maintained that status for at least 12 months. Among 27 patients followed for at least three years, one had cancer return in the same area.
These results do not establish that the cancer will never return. Because the accelerated approval rests on interim trial results, the sponsor must continue following patients to demonstrate lasting clinical benefit.
Safety and discussions with the cancer care team
Jemperli can cause the immune system to attack healthy organs and tissues. These reactions can be severe or fatal. The most common side effects, reported in at least 15% of patients treated for this type of rectal cancer, were fatigue, rash, diarrhea and itching.
People considering this option need an oncology team’s assessment of their cancer stage, prior treatment and tumor-test results. A discussion should address the potential to avoid other treatments, serious immune-related risks and uncertainty about long-term outcomes. This approval is not a reason to stop or change treatment without professional medical advice.
Frequently Asked Questions
Is Jemperli approved for everyone with rectal cancer?
No. This approval is limited to adults with previously untreated stage II or III locally advanced rectal cancer that tests dMMR or MSI-H using an FDA-authorized test.
Does this guarantee that surgery will not be needed?
No. Almost three-fourths of AZUR-1 participants had not needed surgery, radiation or chemotherapy at the reported follow-up, but longer-term outcomes remain under study.
Why is the approval called accelerated?
It is based on interim trial results. Continued patient follow-up is required to confirm that the responses translate into lasting clinical benefit.
